MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ORISE¿ GEL; SUBMUCOSAL INJECTION AGENT

Model Number M00519221

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/29/2022

Event Type  malfunction  

Event Description

Orise lifting gel syringe tip broke off prior to injection.This happened on two products back-to-back.No harm to patient as this the malfunction happened prior to use with the patient.

• Brand Name: ORISE¿ GEL
• Type of Device: SUBMUCOSAL INJECTION AGENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14731614
• MDR Text Key: 294252061
• Report Number: 14731614
• Device Sequence Number: 1
• Product Code: PLL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: M00519221
• Device Lot Number: 28495035
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2022
• Event Location: Outpatient Diagnostic Facility
• Date Report to Manufacturer: 06/17/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA
• Patient Sex: Female